Early phase II Study of TAC-401

Early phase II study of TAC-401 in H. pylori-positive subjects. -Eradication of H. pylori-

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221982

Enrollment

108

Registered

2012-12-17

Start date

2012-12-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

H. pylori infection

Interventions

investigational material(s) Generic name etc : TAC-401 INN of investigational material : Therapeutic category code : 232 Agents for peptic ulcer Dosage and Administration for Investigational material

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Subjects who have H. pylori confirmed based on rapid urease test. -Subjects who have no active peptic ulcer.

Exclusion criteria

Exclusion criteria: -Subjects who have received H. pylori eradication treatment. -Subjects with pyloric stenosis. -Subjects with upper gastrointestinal tract disease (reflux oesophagitis etc.) to require treatment. -Subjects with current or previous history of gastric acid hypersecretion disorders (Zollinger-Ellison syndrome etc.). - Subjects with current or previous history of allergic reaction. -Subjects who have received gastrectomy or vagotomy.

Design outcomes

Primary

Measure	Time frame
H. pylori eradication rate Urea breath test	—

Secondary

Measure	Time frame
Serum gastrin level. The serum pepsinogen I and II level and pepsinogen I / II ratio. Incidence of adverse event and side effect. Antibacterial activities of clarithromycin, amoxicillin, methronidazole, levofloxacin and TAC -401 against H. pylori. Blood test, Cultural method	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026